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Enanta Pharmaceuticals Reports Topline Data from the RSVP Study of EDP-938 in Otherwise Healthy Adults with Community-Acquired Respiratory Syncytial Virus (RSV)
Study Did Not Meet Primary Endpoint of Clinical Symptom Reduction or Secondary Antiviral Endpoints Statistically Significant Percent of Subjects Who Received
About this update from Enanta Pharmaceuticals, Inc.
[{"type":"text","content":"\n\nStudy Did Not Meet Primary Endpoint of Clinical Symptom Reduction or Secondary Antiviral Endpoints\n\n\nStatistically Significant Percent of Subjects Who Received EDP-938 Achieved Undetectable RSV RNA at End of Treatment\n\n\nEDP-938 was Safe and Well-Tolerated\n\n\nEDP-938 Continues to be Evaluated in Ongoing and Planned Clinical Studies in High-Risk Populations\n\n\n WATERTOWN, Mass.--(BUSINESS WIRE)--\nEnanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported topline results for RSVP, its Phase 2b study evaluating EDP-938, a potent N-protein inhibitor, in otherwise healthy adults with community-acquired RSV. In this low-risk patient population which had mild, self-resolving upper respiratory tract infection, EDP-938 did not meet the primary endpoint of reduction in total symptom score compared to placebo, or the secondary antiviral endpoints. However, a statistically significant difference in the number of subjects achieving undetectable RSV RNA at the end of treatment at Day 5 was observed with EDP-938 compared to placebo (p=0.033). Further, EDP-938 demonstrated a favorable safety profile, consistent with that observed in approximately 500 subjects exposed to date. Enanta continues to evaluate EDP-938 in high-risk populations in ongoing and planned clinical studies, including pediatric patients, adult hematopoietic cell transplant recipients, and a high-risk adult population, all of which have the most significant unmet need.\n\n“While RSVP did not meet the study endpoints, we are pleased to observe a statistically significant difference in the number of subjects achieving undetectable RSV RNA at the end of treatment with EDP-938, making this the only study that has demonstrated a statistically significant antiviral effect in an otherwise healthy adult population with community-acquired RSV. The effect on RSV RNA viral load is consistent with EDP-938’s mechanism of action of inhibiting viral replication,” said Jay R. Luly, President and Chief Executive Officer of Enanta Pharmaceuticals. “Although patients were treated within 48 hours of symptom onset, a key observation in this study was that the viral load and symptoms had already peaked and were declining at the time of the first dose, indicating ...